Head and neck cancer
Conditions
Interventions
3 courses of CDDP every 3 weeks during radiation therapy
Sponsors
Niigata University, Faculty of Medicine
Niigata Cancer Center Hospital Niigata City General Hospital Nagaoka Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pathologic or cytologic diagnosis of head and neck squamous cell carcinoma treated with radical CCRT, ie, whole-neck irradiation including bilateral levels II-IV 2)Initial chemotherapy 3)Measurable or evaluable lesions 4)Performance status(PS) 0-1 5)Age 20-75 years 6)No complication that might affect treatment 7)No other cancer 8)Normal liver, kidney, and marrow function White blood cells >3,000/ mm3 Neutrophilic >1,500/mm3 Blood platelet >100,000/mm3 Total bilirubin normal AST and ALT normal Creatinine normal Ccr or eGFR >60ml/min 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Past history of serious drug hypersensitivity 2)Presence of other cancer 3)Clinically problematic infectious disease 4)>1 complication that might affect treatment 5) Nonradical treatment indicated 6)Pregnant or nursing women and those with the possibility of pregnancy 7)Mental or neurologic disease that might affect participation 8)Participation judged by physician to be inadvisable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decision of MTD and DLT (phase I) Rate of CCRT completion (phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| The adverse effect, rate of CCRT completion (Phase I) Renal dysfunction more than grade 2, response rate, inflammation of mucosa more than grade 3, rate of chemotherapy completion (Phase II) | — |
Countries
Japan
Contacts
Public ContactHiroshi Matsuyama
Niigata University, Faculty of Medicine Otolaryngology, Head and Neck
Outcome results
None listed